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IMB Newsletter Issue No. 36 May - August 2010

17 September 2010

Download: IMB Newsletter Issue No. 36 May - August 2010

General

  • Signing of Memorandum of Understanding between The Therapeutic Goods Administration of Australia and the IMB
  • Herbal medicines on the Irish market 2010
  • Authorisation or registration numbering system

Human Medicines

  • Project to update the legal status of centrally authorised medicinal products
  • Change in the procedure for requesting Ireland to act as Reference Member State (RMS) in a decentralised procedure for a human medicinal product

Veterinary Medicines

  • Collection of data on veterinary consumption of antimicrobials
  • Update on status of flukicides without MRL for milk
  • Staff changes

Compliance

  • Requirements for QP declarations for inclusion of third-country contract manufacturers/testing facilities for IMP authorisation
  • Meeting of the PIC/S Expert Circle on active substances
  • Persistent Organic Pollutants Regulations 2010, S.I. No. 235 of 2010 ('POPs Regulations')
  • Reporting of quality defects
  • Micronisation of active substances
  • Controlled drugs - update to Misuse of Drugs Regulations 2010
  • Use of small volume cold chain insulated shippers
  • Cosmetics update
  • Joint inspections with the US FDA (notice reprinted from EMA website)
  • GMP and market compliance information day

 





Date Printed: 16 April 2014

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